Alzheimer's disease is the most common form of dementia afflicting as many as 5.3 million Americans. The disease is generally believed to be caused by the accumulation of β-amyloid plaques in the brain, resulting in nerve cell death and concomitant reduction in neurotransmitters levels. Impairment in memory, cognition, reasoning, and judgment results along with the decrease in emotional stability and development of behavioral problems. The disease is progressive leading to profound mental deterioration and ultimately death.
There is no known cure for the Alzheimer's disease. Patient care primarily focuses on the management of symptoms of this disease. Disease progression in Alzheimer's patients can be monitored in terms of reduction in brain tissue volume, or enlargement of ventricular volume, over time. Afforded by technologies such as magnetic resonance imaging (MRI), these image-based monitoring techniques are advantageous in their ease to administer and to quantify any changes in the brain condition. The recent discovery that antibodies against β-amyloid are present in human immunoglobulin preparations (e.g., intravenous immunoglobulin or IVIG) and can inhibit the neurotoxic effects of β-amyloid lead to clinical trials in Alzheimer's patients. Disease stabilization and modest improvement in cognitive ability were noted.
In 2006, there were 26.6 million Alzheimer's disease sufferers worldwide. By 2050, a predicted 1 in every 85 people will be diagnosed globally. Given the dire nature of this disease, the large patient population, and the tremendous burden on care givers, a pressing need exists for new and more effective therapeutic agents and methods. The present invention provides improvements to fulfill this and other related needs.